Clinical Trials /

A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU)

NCT03033511

Description:

This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, and multicenter study to evaluate the efficacy of rovalpituzumab tesirine as maintenance therapy following first-line platinum-based chemotherapy.

Related Conditions:
  • Small Cell Lung Carcinoma
Recruiting Status:

Terminated

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT03033511

Trial Eligibility

Document

Title

  • Brief Title: A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU)
  • Official Title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects With Extensive Stage Small Cell Lung Cancer (MERU)

Clinical Trial IDs

  • ORG STUDY ID: M16-298
  • SECONDARY ID: 2016-003503-64
  • NCT ID: NCT03033511

Conditions

  • Small Cell Lung Cancer

Interventions

DrugSynonymsArms
Placebo for dexamethasonePlacebo
Placebo for rovalpituzumab tesirinePlacebo
Rovalpituzumab tesirineRovalpituzumab tesirine/dexamethasone
DexamethasoneRovalpituzumab tesirine/dexamethasone

Purpose

This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, and multicenter study to evaluate the efficacy of rovalpituzumab tesirine as maintenance therapy following first-line platinum-based chemotherapy.

Trial Arms

NameTypeDescriptionInterventions
Rovalpituzumab tesirine/dexamethasoneExperimentalRovalpituzumab tesirine/dexamethasone every 6 weeks (q6 wk); omitting every third cycle
  • Rovalpituzumab tesirine
  • Dexamethasone
PlaceboExperimentalPlacebo q6 wk; omitting every third cycle
  • Placebo for dexamethasone
  • Placebo for rovalpituzumab tesirine

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically or cytologically confirmed extensive-stage disease small cell lung
             cancer (ED SCLC) at initial diagnosis with ongoing clinical benefit (stable disease
             [SD], partial response [PR], or complete response [CR]) following completion of 4
             cycles of first-line platinum-based therapy

          -  Participant is eligible to be randomized at least 3 but no more than 9 weeks from Day
             1 of the fourth cycle of first-line platinum-based chemotherapy.

          -  Participants with a history of central nervous system (CNS) metastases prior to the
             initiation of first-line platinum-based chemotherapy must have received definitive
             local treatment and have documentation of stable or improved CNS disease status

          -  Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1

          -  Participants must have adequate bone marrow, renal and hepatic function

          -  Availability of archived or representative tumor material for assessment of DLL3
             expression

        Exclusion Criteria:

          -  Any prior systemic chemotherapy, small molecule inhibitors, immune checkpoint
             inhibitors, other monoclonal antibodies, antibody-drug conjugates,
             radioimmunoconjugates, T-cell or other cell-based or biologic therapies, or any other
             anti-cancer therapy than that described in inclusion criteria for SCLC.

          -  Any disease-directed radiotherapy (except prophylactic cranial irradiation, palliative
             radiotherapy to a radiographically documented non-progressing lesion for symptom
             control, or pre-planned radiotherapy for CNS metastases present prior to start of
             first-line therapy and non-progressing) after last dose of first-line chemotherapy.

          -  Prior exposure to a pyrrolobenzodiazepine (PBD-based) or indolinobenzodiazepine-based
             drug, prior participation in a rovalpituzumab tesirine clinical trial, or known
             hypersensitivity or other contraindications to rovalpituzumab tesirine or excipient
             contained in the drug formulation.
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Survival (OS) in Participants With Extensive-Stage Small Cell Lung Cancer With Delta-Like Protein 3 High Expression in Tumor (DLL3high)
Time Frame:Survival follow-up continued until the endpoint of death, participant was lost to follow-up or withdrew consent, or termination of the study by AbbVie, whichever occurred first. Median time on study overall was 11.9 months.
Safety Issue:
Description:OS is defined as the number of months from randomization to death of any cause. Calculated using the Kaplan-Meier methodology.

Secondary Outcome Measures

Measure:OS in All Randomized Participants
Time Frame:Survival follow-up continued until the endpoint of death, the subject was lost to follow-up or withdrew consent, or termination of the study by AbbVie, whichever occurred first. Median time on study overall was 11.9 months.
Safety Issue:
Description:OS is defined as the number of months from randomization to death of any cause. Calculated using the Kaplan-Meier methodology.
Measure:Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) Physical Functioning Domain Over Time
Time Frame:Baseline, Weeks 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, Final Visit (up to Week 78)
Safety Issue:
Description:The EORTC QLQ-C30 is composed of global health status/QoL scale; five functional domains (physical, role, emotional, cognitive, and social); three symptom domains (fatigue, nausea and vomiting, and pain); and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The Physical Functioning domain includes 5 questions in which participants were asked to rate their overall health and overall quality of life as it relates to physical functioning during the past week on a scale from 1 (very poor) to 7 (excellent). The 5 scores were averaged and transformed to a scale from 0 to 100, where a high score represents a high QoL. A positive change from baseline indicates better quality of life.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Terminated
Lead Sponsor:AbbVie

Trial Keywords

  • Extensive-Stage Small Cell Lung Cancer (ED SCLC)
  • Cancer
  • Platinum-Based Chemotherapy
  • Rovalpituzumab tesirine
  • first-line chemotherapy
  • Small Cell Lung Cancer (SCLC)
  • Delta-like protein 3 (DLL3)

Last Updated

July 29, 2021